Acetaminophen alone versus acetaminophen plus ibuprofen for pain after cesarean delivery
Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
This will see if adding intravenous ibuprofen to IV acetaminophen gives better pain relief than acetaminophen alone for people after an elective cesarean delivery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06479122 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional study compares IV acetaminophen alone to a combined IV acetaminophen/ibuprofen product (Maxigesic® IV) given as part of multimodal analgesia after elective cesarean section. Participants scheduled for term elective cesarean (≥37 weeks) will receive one of the two analgesic regimens and have postoperative pain scores and analgesic use recorded. The trial is conducted at a single center, Seoul National University Hospital, with standard perioperative care otherwise unchanged. Key exclusions include emergency cesarean, multiple pregnancy, significant liver or kidney disease, NSAID or acetaminophen hypersensitivity, and other contraindications listed in the protocol.
Who should consider this trial
Good fit: Ideal candidates are people having an elective cesarean at term (≥37+0 weeks), meeting weight and organ-function criteria and without contraindications to acetaminophen or ibuprofen.
Not a fit: People with contraindications such as NSAID or acetaminophen allergy, liver or kidney disease, peptic ulcer/upper GI bleeding, asthma related to NSAIDs, multiple pregnancy, low body weight, or those undergoing emergency cesarean are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combination regimen could provide better postoperative pain control and reduce opioid requirements after cesarean delivery.
How similar studies have performed: Previous randomized trials have shown that combining acetaminophen (paracetamol) with ibuprofen improves postoperative pain control and reduces opioid use compared with acetaminophen alone, so this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective cesarean section * Gestational age \> 37+0 weeks Exclusion Criteria: * Emergency cesarean section * Multiple pregnancy (e.g. twins, triplets) * Body weight \< 50 kg * Preeclampsia * History of hypersensitivity to acetaminophen or ibuprofen * History of upper gastrointestinal tract bleeding or gastric ulcer * Underlying liver disease * Underlying kidney disease or GFR \< 90 mL/min/1.73m2 * Heart failure or severe hypertension * History of asthma * Chronic use of barbital or tricyclic antidepressants
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hansol Kim, MD
- Email: hansolfrkr@gmail.com
- Phone: +82-10-3160-1548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.